Dental treatment compositions and conformable dental treatment trays using the same

ABSTRACT

The present invention is a formable dental treatment tray utilizing poly(2-ethyl-2-oxazoline) and a gelatinous active. Blending of the active is accomplished by mixing the Poly(2-ethyl-2-oxazoline) with an active ingredient, such as a peroxide like hydrogen peroxide, carbamide peroxide, sodium perborate, or sodium percarbonate, usually also with water or an appropriate organic solvent. Peroxide concentrations in these new gels can reach a 30% concentration of hydrogen peroxide while maintaining a shelf life of six months at room temperature without developing peroxide decomposition. The gels are applied to an appropriate backing and dried to a gelatinous state. In use, the active is hydrated and regains adhesiveness. Then the tray is pressed and formed around a user&#39;s dental arch to form the customizable tray. Multiple active ingredients may be used, with or without peroxide, for accomplishing desired treatment regimens.

CROSS-REFERENCES TO RELATED APPLICATIONS

This Application claims priority as a Continuing-in-part application ofprior filed U.S. Non-provisional application Ser. No. 11/307,463, filedon Feb. 8, 2006. This parent application is expressly incorporated byreference herein in its entirety

FIELD OF THE INVENTION

The present invention relates to the field of thickeners and moreparticularly relates to a thickener for the production of a stablevisco-elastic medium for the storage and delivery of peroxide and otheractive ingredients, particularly hydrogen peroxide and its adducts inthe form of a dental tray, and the products manufactured using the same.

BACKGROUND OF THE INVENTION

Inorganic peroxide is usually defined as hydrogen peroxide and adductsthereof. Some examples are: hydrogen peroxide, carbamide peroxide,sodium percarbonate, sodium perborate. Peroxide is used in manydifferent applications from an antiseptic for minor wounds to bleach forteeth, hair and laundry. Solutions of varying strengths of hydrogenperoxide are readily on the market, usually in a liquid form.

For targeted bleaching applications, such as tooth whitening, it can bedesirable to blend the peroxide into a gel by blending the peroxide witha thickener. Blending is accomplished by mixing the thickener with theperoxide, usually also with water or an appropriate organic solvent.However, due to the volatile oxidizing nature of peroxide (which impartsthe substance's bleaching ability); there are very few thickeners thatcan withstand a peroxide environment. Most polymers will degrade quicklyin a peroxide environment and will lose their thickening propertiesentirely due to the powerful oxidizing effects of peroxide. These gelswill degrade into thin, water-type consistencies. It is rare to find apolymer that can withstand, for prolonged periods of time, the powerfuleffects of peroxide.

Chemists have diluted hydrogen peroxide in order to tame its instabilityand raw oxidizing power. Liquid hydrogen peroxide is common and is byfar the most aggressive oxidizer and the most unstable. Chemists havealso produced adducts of hydrogen peroxide to stabilize hydrogenperoxide in the resultant compounds. The main adducts of hydrogenperoxide that are used for bleaching are: urea hydrogen peroxide(carbamide peroxide), sodium perborate, and sodium percarbonate.However, dilution of hydrogen peroxide by any means, while increasingstability, also reduces the bleaching efficacy of resultant gels.Carbamide peroxide contains about 36% hydrogen peroxide by weight.Therefore, a bleaching gel made with about 10% carbamide peroxide (whichis an industry standard), yields only about 3% hydrogen peroxide. Sodiumpercarbonate has an even lower concentration of hydrogen peroxide. Theuse of these adducts then, generates an instant upper limit to the finalconcentration of hydrogen peroxide in a product.

Dental whitening manufacturers have predominately been using carbamideperoxide. Carbamide peroxide is docile enough to be used with manypolymers that would not work with hydrogen peroxide. The most usedcommercial thickener, CARBOPOL, is a good example of this. CARBOPOL is agood thickener for carbamide peroxide. However, CARBOPOL does not holdup to pure hydrogen peroxide for even short amounts of time. WhenCARBOPOL is used in a composition containing 30% hydrogen peroxide, thecomposition will begin to break down and form peroxide decompositionbubbles in about two weeks. Therefore what is needed is a polymer thatis capable of withstanding hydrogen peroxide compositions for moderateamounts of time.

The direct application of these manufactured gels and liquids to theteeth for the purpose of bleaching does have drawbacks. Direct deliveryof these gels and liquids onto the teeth can be unsuccessful as theytend to run-off the teeth by the force of gravity. They also are subjectto being wiped off quickly by the cheeks and gums. To make mattersworse, the saliva is also there to quickly wash and dilute any treatmentfluids off of the teeth. While gels may be more resistant to thesedrawbacks as compared to other liquids, they still have these inherentdifficulties.

In order to overcome the difficulties inherent in the direct applicationof fluidic treatment materials various inventions have been developed.One of the early inventions involved an insoluble barrier that wouldhold the treatment gels and liquids against the teeth and at the sametime protect it against the tongue, cheek and saliva. This resulted inthe invention of the plastic dental tray. The major drawback in theconcept of a tray is that the variations in teeth anatomy make it verydifficult to make and design a generic one-size-fits-all tray. Thereforesome of the early trays were designed to fit onto the gums andmechanically pinch the gums in order to hold the tray onto the teeth.These mechanical trays were cumbersome and painful for patient use andbecame obsolete in favor of the custom tray. The custom tray involvescreating an impression of the teeth, followed by casting a mold of saidimpression. Said mold is then covered with a pre-heated semi-moltenplastic sheet with a vacuum in place in order to force the plastic toadapt to the casting's surface. Finally, the post-solidified tray isusually trimmed with scissors into a custom tray for a specificindividual. The drawback to the custom tray is the amount of time andresource and effort needed to create one. The biggest drawback inherentin all trays of the prior art is their accompanying use of fluidictreatment gels and liquids. Once a tray is created it must be filledwith a fluidic treatment gel or liquid and, most of the time, thepatient must do this.

Early dental treatment products were liquids. Liquids were mostespecially difficult to handle, as they tend to run out of the trays andwere easily spilled while filling the trays. Liquids were abandoned asthe product of choice in favor of higher viscosity fluidic gels. Gelsprovide more control over flow characteristics than liquids. A gel canobtain higher viscosities that limit the flow of treatment productsthereby allowing the treatment product to remain in the tray better. Agel also adds the benefit of some adhesion between the tray and teethaiding in holding the tray in place once fitted. The drawback inherentto these fluidic gels and liquids is that they are messy for bothpatient and practitioner. When these fluidic gels and liquids spillwhile filling the tray or express out of the tray while fitting andwearing the tray; they are a nuisance and a complaint of patients. Theseare the drawbacks of fluidic treatment products and trays:

-   -   a. While filling trays, any spill is messy and a nuisance to        clean up.    -   b. When fitting the filled tray onto the teeth, the teeth must        displace the treatment fluids and any excess gel or liquid will        be forced out of the tray and into the mouth. In the case of        gels this becomes especially messy, since it cannot be easily        spit or rinsed out. The current procedure calls for a toothbrush        to agitate the gel and with copious amounts of dilution water,        the patient will eventually work away the excess gel.    -   c. While wearing the trays, the upper teeth constantly come in        contact with the lower teeth in a natural repetitive soft biting        action. This natural biting action acts as a pump that when        compressed will force more messy gel or liquid material out of        the tray where it must be cleaned off or drowned in saliva. When        the compression ends and the trays relax back into equilibrium        it will either begin to empty out the tray and fill it with        saliva (so the upper portion of the teeth are not treated) or        they begin mixing and dilute the active ingredients.

Another invention of the prior art that is used to deliver treatmentgels and liquids is the dental strip. The dental strip is an insolubleflexible plastic strip onto which the treatment fluidic gels have beenapplied. Liquid treatment products obviously would not work well withstrips, since they would just run-off the strip. The dental strip isthen applied to the teeth. Current dental strips even incorporate intheir design shallow pockets into the plastic strip in order to holdfluidic treatment gels. The lack of these shallow pockets would limitthe amount of treatment gel available for actual treatment after fittingthe strip in place, as most of the gel would be displaced from a smoothsurface during fitting. The drawbacks of these prior art dental stripsare again their reliance on gels for functionality. Gels suffer frommany of the same problems as trays, in that while fitting and wearingthe strip any excess gel that is displaced or pumped out ends up in themouth as a constant mess. In some respects the strips are worse than thetrays, since they are not tray shaped they must hold their shape againstthe teeth by either the adhesiveness of the gel or the rigidity of thebacking material or they tend to unfold off the teeth during use. Stripsthat use gels also suffer from movement on the teeth during use. Thegels act as a slimy lubricant between the teeth and strip, which allowsthe strip to annoyingly move around while it is being worn. Patientscomplain when they have to constantly adjust the strip back into place.One of the biggest complaints with strips that use gels is with patientswith uneven teeth, the strip tends to favor the tooth that sticks outand fails to contact adjacent teeth creating a gap between the strip andteeth that allows saliva to enter, which dilutes and washes away thegel.

Other disclosed inventions include more rigid or solidified treatmentcompositions that are set into a tray or onto a backing material. Thesesolidified compositions can be sufficiently rigid as to maintain itselfin a tray-like configuration absent their external supports. Othersdisclose a strip or a tray with a two-part treatment composition that ismixed and applied to the backing material just prior to use. These2-part prior art compositions are incapable of being combined in apre-mixed shelf stable treatment device. When combined, the resultantcompound eventually sets to a rubber-like consistency and is placedagainst teeth; however, this is an unstable state. Over time, thecompound decomposes into a dry powder and degraded peroxide. This is whythis type of prior art system must be separated into 2 parts and mixedonly upon patient use. These systems require the patient or clinician tomake/mix the rubber-like substance first and then somehow load this samerubber-type consistency compound onto a whitening device prior toapplication to the patients teeth—this is too cumbersome.

These more rigid treatment compositions are an improvement over gel orliquid compositions, since they resist flow they tend to stay on thebacking strip or tray when fitting and wearing the implements. So theydo not pump out of the tray or displace out of the dental strip whenfitting. However, they do crack and break if flexed. The odd product isthe dry or wet type patches that do not have a backing strip or tray.The drawback to patches is that they do not have a barrier between theback of the patch and the mouth; therefore they are again subject to thewiping effect of adjacent oral tissues and the washing and dilutioneffects of saliva. Another drawback is the lack of barrier means notonly the active ingredient is treating the teeth but also treating allthe oral tissues on the other side. Many of these active ingredients areirritating or harmful to soft tissue; the patch is not much of animprovement over gels and liquids that are placed in strips or trays.

The drawback to more rigid treatment compositions placed in trays ordental strips is that they are limited to non-toxic, active ingredientstable, water-soluble thickeners of the prior art. Many of thesethickeners have physical characteristics so that when they are driedfrom an aqueous state, they are not ideal for a tray or a dental strip.The ideal thickener would have these characteristics:

-   -   a. Adhesion in aqueous environment: that when the surface of the        more rigid composition becomes wetted it becomes sticky. Many        thickeners do not have sufficient stickiness to overcome the        forces exhibited while fitting and wearing a tray or strip to        uneven teeth. The adhesion should be great enough to hold the        backing strip or tray to all varieties of teeth whether straight        or crooked.    -   b. Hygroscopic: The water-soluble thickener should be able to        resist drying to a powder over long periods of storage before        use. Many thickeners tend to dry out even when sealed in their        packages over time leaving condensation inside the package or        may even just escape the packaging altogether. A hygroscopic        thickener allows you to use and keep water in the formulation        during storage because hygroscopic gels will retain an aqueous        equilibrium of internal water and resist drying to a powder.        This amount of internal water can be adjusted as it is directly        proportional to the drying temperature; therefore, drying times        and temperatures can be adjusted to adjust the visco-elasticity        of the final product. Thickeners that dry out are limited to        formulations that contain non-volatile solvents to keep them        intact. The problem with these formulations is they tend to wet        more slowly reducing short-term adhesion. Many thickeners will        not even create a gel without water as one of the solvents.    -   c. Compatible with organic solvents: The ideal thickener should        be able to incorporate organic solvents to manipulate and adjust        various properties. These water-soluble thickeners that can also        incorporate organic solvents are adjustable in their elasticity,        plasticity, solubility, tackiness and viscosity by the        appropriate use of various organic solvents. A water-soluble        thickener that does not incorporate organic solvents is left        with only water as the modifier of choice.    -   d. Elasticity: The ideal thickener would have sufficient        elasticity, without splitting or cracking during storage or        while fitting the implement. Some devices of the prior art are        of a composition that has a rigidity so as to maintain itself in        the shape of its container even when the external support is        removed. These compositions have essentially dried out and are        solid and brittle. Many rigid compositions of the prior art are        dried solids adjacent a strip or tray. The backing strip and        tray are usually flexible yet the dried composition is brittle        and tends to crack when manipulating the implement. There is a        drawback to dry and brittle compositions in that they need lots        of water to become hydrated to a point where the active        ingredients become “active”. These dry compositions will tend to        draw the water out of the initial wetted layer, thus drying out        the surface into a less mobile layer. Also many active        ingredients are volatile and would simply evaporate when dried;        others are only stable in the presence of water and would        inactivate the product if it were dried out. Finally a dried        composition tends to lose its adhesiveness and become loose from        the backing strip or tray and falls out.

What is needed is a thickener that demonstrates all of the abovecharacteristics that can be conjoined to a film, backing strip, backingsheet or tray in order to more efficiently deliver the activeingredients to the teeth and gums. Poly(2-ethyl-2-oxazoline) is a watersoluble thickener with ideal properties attuned to the creation ofpre-mixed, shelf stable compositions that may take the form of gels,visco-elastic and gelatinous compositions, that are intended to releasean active ingredient. These compositions can be matched to a backingmaterial in various designs and shapes such as a tray or dental strip.

The present invention represents a departure from the prior art in thatthe application of the present invention in peroxide gels allows forhigher peroxide concentrations by providing a gel base that issurprisingly stable in a peroxide environment. The resultant gels mayuse pure hydrogen peroxide at concentrations where only adducts havebeen used in the prior art, thereby doubling or tripling the resultantconcentration of hydrogen peroxide in the finished product whilesimultaneously providing comparable or superior gel stability. Thepresent invention also presents the gels in a stable, gelatinous,visco-elastic form that is easily packaged and stored, and provides adelivery system for the same. When placed on a flexible backing, thegelatinous active component acts as a flexible adhesive that will adhereto a user's dental arch and have the thickness and elasticity to remainin place. The final product, then, is a conformable dental treatmenttray that will shape itself to any particular irregularities of a user'sdental arch. Therefore, it is truly customizable for the user, unlikeprior art constructs.

For purposes of this Application, the term “gelatinous” shall have thedefinition given first in the American Heritage Dictionary of theEnglish Language, Fourth Edition, © 2006 by Houghton Mifflin Co.:“resembling gelatin, viscous.” A gelatinous compound shall be avisco-elastic compound having physical deformation properties between asolid and a fluid. A solid shall be defined as a substance that issufficiently rigid so that it maintains its form indefinitely,independent of any structure or support. A fluid shall be defined as asubstance that will conform and coalesce to the shape of a beaker intowhich multiple samples of the same substance are placed, within 10minutes, with hand agitation of the container and/or hand mixing with animplement at 25° C. with an atmospheric pressure of 1 ATM. Therefore, agelatinous compound, as the term is used in this Application, will havesome degree of flex and deformation as required to fit inside acontainer, but will not coalesce so that a specific sample or portionsthereof are still determinable. This is particularly evident if a numberof discrete units of gelatinous material are placed in a container—theywill bend as they contact the container but will not merge into onebody.

SUMMARY OF THE INVENTION

In view of the foregoing disadvantages inherent in the known types ofthickeners for peroxide gels, this invention provides an improvedthickener. As such, the present invention's general purpose is toprovide a new and improved thickener that is capable of maintaining agel consistency for a peroxide gel while allowing for higher peroxideconcentrations to increase efficacy.

Chemical solutions and gels containing hydrogen peroxide are well knownin the art. In principle, the solutions and gels are made by combining aperoxide, solvents and a thickening agent. Varying degrees of viscosityand strength are easily generated by altering the base components'proportions and identities. For the purpose of this application, thepreferred embodiment will be described as a dental whitening gel, thoughmany other applications may be easily conceived and should be deemed tobe included in this Application and its claims. Such additionalapplications include bleaching products for hair or laundry, whereviscosity may not be as important as with a dental gel, but theprinciples and invention described herein, namely higher viscosity andbleaching strength, are equally applicable.

The novel thickening agent is Poly(2-ethyl-2-oxazoline). It is a polymerthat swells upon absorption of liquids. Poly(2-ethyl-2-oxazoline)creates very viscous gels. There are many different molecular weights ofPoly(2-ethyl-2-oxazoline) available commercially. These can be chosen toimpart different physical properties to the gel for bleaching and otherapplications.

Poly(2-ethyl-2-oxazoline) is surprisingly a polymer that is capable ofexcellent compatibility with peroxide and imparts excellent thickviscous properties to the gel. Experience has shown that a 30% hydrogenperoxide gel made with Poly(2-ethyl-2-oxazoline) stays a gel during sixmonth's storage at room temperature. Poly(2-ethyl-2-oxazoline) is asuperior polymer in an oxidizing peroxide environment to currentthickening polymers like CARBOPOL, silica, PVP, and polyethyleneglycols.

One particular use of the combination of Poly(2-ethyl-2-oxazoline) andperoxide, and the focus of this application, is the creation of aformable dental treatment tray for the purpose of treating teeth. Whenperoxide is mixed with Poly(2-ethyl-2-oxazoline), with a solvent in thecase of powdered peroxides, and the resulting combination isappropriately dried, the resultant product is a hygroscopic, gelatinous,visco-elastic substance that is less adhesive than a gel, is wellpackaged, relatively inert and behaves well in product production. Whenwater is added to the surface of the substance, the substance regainsthe adhesiveness lost in the drying process and may be applied directlyto a user's teeth in a manner that conforms to that individual user'sdental arch. The gels may be applied to a tape-like backing, such asPARAFILM, dried, cut into appropriate shapes, like a strip, and packagedfor a particularly effective bleaching tray to be used in clinical orhome applications.

Packaging of the product must resist moisture as the hygroscopic natureof the product will tend to absorb atmospheric moisture and alter itsvisco-elastic qualities.

The more important features of the invention have thus been outlined inorder that the more detailed description that follows may be betterunderstood and in order that the present contribution to the art maybetter be appreciated. Additional features of the invention will bedescribed hereinafter and will form the subject matter of the claimsthat follow.

Many objects of this invention will appear from the followingdescription and appended claims. Before explaining at least oneembodiment of the invention in detail, it is to be understood that theinvention is not limited in its application to the details ofconstruction and the arrangements of the components set forth in thefollowing description or illustrated in the drawings. The invention iscapable of other embodiments and of being practiced and carried out invarious ways. Also it is to be understood that the phraseology andterminology employed herein are for the purpose of description andshould not be regarded as limiting.

As such, those skilled in the art will appreciate that the conception,upon which this disclosure is based, may readily be utilized as a basisfor the designing of other structures, methods and systems for carryingout the several purposes of the present invention. It is important,therefore, that the claims be regarded as including such equivalentconstructions insofar as they do not depart from the spirit and scope ofthe present invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of gel being placed on a backing to createa tray according to the present invention.

FIG. 2 is a perspective view of the tray of FIG. 1 being dried.

FIG. 3 is a perspective view of a finished tray.

FIG. 4 is a perspective view of the tray of FIG. 3, being hydrated.

FIG. 5 is a perspective view of the tray of FIG. 4, being folded priorto positioning.

FIG. 6 is a perspective view of the tray of FIG. 2 being formed to auser's upper dental arch.

DETAILED DESCRIPTION OF THE INVENTION

The preferred embodiments of the peroxide gels used to create thedeformable trays according to the precepts of this invention are hereindescribed. It should be noted that the articles “a”, “an” and “the”, asused in this specification, include plural referents unless the contentclearly dictates otherwise.

Poly(2-ethyl-2-oxazoline) is commercially available in 50,000, 200,000and 500,000 M.W. Varying viscosities and longevity of gels may becreated based on the amount and weight of Poly(2-ethyl-2-oxazoline) usedand the desired strength of peroxide. As a guide, dental gels arepreferred to be a viscosity between 1000 and 200,000 centipoise. In suchranges, peroxide concentrations may reach up to 50% hydrogen peroxideusing Poly(2-ethyl-2-oxazoline) as a thickener. In its preferred form, a30% concentration may be obtained with a shelf life of six months atroom temperature. The simplest preferred gel is obtained by mixing 50%strength hydrogen peroxide with 200,000 M.W. Poly(2-ethyl-2-oxazoline)in a ratio of 6:4. Additional strengths of peroxide gels may be obtainedby utilizing additional solvents and different molecular weights ofPoly(2-ethyl-2-oxazoline). Some common solvents include: water, ethanol,polyethylene glycols, polypropylene glycols, glycerin, and propyleneglycol. Any of these may be added for varying the consistency andproperties of the gels created. However, each gel must be developed withthe basic limitation that the strength of the peroxide in the gel makesthe gel inherently more unstable.

In the present invention, the resultant gels 15 are placed on preformedpieces of a backing 13, such as PARAFILM (a polymeric wax mixture), asshown in FIG. 1. The backing provides stability for the resultantsubstance and a surface with which the tray may be touched formanipulation. The gels 15 are then dried through conventional processes.Typical drying may be performed at temperatures of approximately 37° C.for 12 to 24 hours (FIG. 2). Drying may also take place in any othersuitable environment, including those of ambient air, room temperature,lower than room temperature, higher than room temperature, or vacuums.Times and temperatures may vary for individual gel composition. Whendried, the gels form a bleaching compound that will conform to a user'sdental arches and form a bleaching tray 10 without cracking or breaking(FIG. 3). The resultant compound is visco-elastic, and gelatinous,having a flexibility and consistency similar to the popular confectionknown as gummi worms, and will deform when removed from the backingmaterial. The resultant tray is initially planar; with a significantbody of gelatinous whitening composition adhered to the backing.

In use, FIGS. 4-6, a user will take a tray 10 and wet it with water 20.The gel will rehydrate and become more adhesive so that the tray willthen be applied to the user's teeth (dental arch 30). The user willpress and form the tray 10 around the dental arch 30 (FIG. 6),conforming it to the individual shape of the arch 30 and, ideallycovering at least one, if not both, sides of the arch 30. The user may,if desired, pre-fold the tray (FIG. 5) before applying it to the teeth.The tray 10 according to the present invention is therefore totallycustomizable and formable, creating a buccal wall 53, a crease/bottom 56and a lingual wall 59. These walls and floor conform exactly to theuser's dental arch 30 (FIG. 6), mimicking the variations andindividualities of a particular user's arch. Once treatment iscompleted, the user simply removes the tray. Additional water may beneeded to complete removal due to the adhesiveness of the tray 10.

Due to the increased peroxide content in the whitening compound, time oftreatment will be less than conventional prior art whitening methods.Treatment may be accomplished in three days, rather than over the courseof a week. As always, a second round of treatment may be initiated, butit is recommended that a user wait at least one day between courses oftreatment due to the increased potency of the product. Longer treatmenttimes and courses may be utilized with lower concentration peroxide gelsand may extend as long as a week of consecutive treatments.

By way of example, the following formulations are supplied as examplesof compositions for the gel according to the present invention. A truebest mode will be dependent upon the desired attributes of the gels, andeventual trays, created. However these examples of possible gels allhave the required consistency and bleaching power required by thepresent invention. It is, of course, to be understood that the followinglist is only for illustration and that any variation of these and othergels will fall within the purview of this invention. Accordingly, it isto be understood that those skilled in the art will be capable offormulating an infinite number of possible gels and, as such, this listshould not in any way be deemed limiting of the invention.

(Composition in % by weight)

Formula #1

-   -   1. 11%—Carbamide Peroxide    -   2. 43%—Poly(2-ethyl-2-Oxazoline) M.W. 500,000    -   3. 27.5%—Purified or distilled water    -   4. 16.7%—Ethanol    -   5. 1.0%—Poly acrylic acid 35% M.W. 100,000    -   6. 0.3%—Sucralose    -   7. 0.4%—Peppermint Oil USP    -   8. 0.1%—Potassium Hydroxide USP

Formula #2

-   -   1. 17%—Carbamide Peroxide    -   2. 40%—Poly(2-ethyl-2-Oxazoline) M.W. 500,000    -   3. 25.5%—Purified or distilled water    -   4. 15.7%—Ethanol    -   5. 1.0%—Poly acrylic acid 35% M.W. 100,000    -   6. 0.3%—Sucralose    -   7. 0.4%—Peppermint Oil USP    -   8. 0.1%—Potassium Hydroxide USP

Formula #3

-   -   1. 23%—Carbamide Peroxide    -   2. 37%—Poly(2-ethyl-2-Oxazoline) M.W. 500,000    -   3. 23.25%—Purified or distilled water    -   4. 14.7%—Ethanol    -   5. 1.0%—Poly acrylic acid 35% M.W. 100,000    -   6. 0.3%—Sucralose    -   7. 0.4%—Peppermint Oil USP    -   8. 0.1%—Potassium Hydroxide USP    -   9. 0.25%—Sodium Fluoride USP

Formula #4

-   -   1. 27%—Carbamide Peroxide    -   2. 33%—Poly(2-ethyl-2-Oxazoline) M.W. 500,000    -   3. 25%—Purified or distilled water    -   4. 13.2%—Ethanol    -   5. 1.0%—Poly acrylic acid 35% M.W. 100,000    -   6. 0.3%—Sucralose    -   7. 0.4%—Peppermint Oil USP    -   8. 0.1%—Potassium Hydroxide USP

Formula #5

-   -   1. 17%—Carbamide Peroxide    -   2. 50%—Poly(2-ethyl-2-Oxazoline) M.W. 200,000    -   3. 20.5%—Purified or distilled water    -   4. 10.7%—Ethanol    -   5. 1.0%—Citric acid 35% M.W. 100,000

6. 0.3%—Aspartame

7. 0.4%—Peppermint Oil USP

8. 0.1%—Potassium Hydroxide USP

Formula #6

-   -   1. 27%—Carbamide Peroxide    -   2. 33%—Poly(2-ethyl-2-Oxazoline) M.W. 500,000    -   3. 25%—Purified or distilled water    -   4. 13.2%—Ethanol    -   5. 1.0%—Malic acid 35% M.W. 100,000    -   6. 0.3%—phenyl alanine    -   7. 0.4%—Banana Flavoring    -   8. 0.1%—Sodium Hydroxide USP

Formula #7

-   -   1. 11%—Hydrogen Peroxide    -   2. 43%—Poly(2-ethyl-2-Oxazoline) M.W. 500,000    -   3. 27.5%—Purified or distilled water    -   4. 16.7%—Ethanol    -   5. 1.0%—Poly acrylic acid 35% M.W. 100,000    -   6. 0.3%—Sucralose    -   7. 0.4%—Peppermint Oil USP    -   8. 0.1%—Potassium Hydroxide USP

As can be seen, other ingredients include flavorings and sweeteners,solvents, plasticizers, and other elements for desired effect. It is, ofcourse, readily conceived that other active ingredients may be added tothe composition for more desired effects, with or without peroxide. Suchactive ingredients may include and are not limited to fluoride,desensitizers, anti-microbials, anti-fungals, re-mineralizers,surfactants, nutraceuticals, pharmaceuticals and other medicaments.While it is not as preferred as Poly(2-ethyl-2-Oxazoline),polyvinylpyrrolidone (“PVP”) may be used in this invention with goodresults. Again, proportions in formulas using PVP will vary according todesired characteristics and purposes.

A specific list of possible additives includes, but is not limited to:

Fluorides—sodium fluoride, potassium fluoride, Stannous fluoride, sodiummonofluorophosphate and alkyl fluoroamines.

Desensitizers—potassium citrate, glutaraldehyde, sodium citrate,potassium nitrate, sodium nitrate and Sodium and potassium salts ofEDTA, and EDTA.

Anti-microbials—chlorhexidine, chlorhexidine gluconate, benzalkoniumchloride, thymol, sodium chlorite, potassium chlorite, triclosan, methylparaben, propyl paraben, sodium benzoate, benzalkonium chloride, cetylpyridinium chloride, zinc chloride.

Anti-fungals: Ketoconazole, potassium permangante, terninafine HCL, zincchloride

Re-mineralizers—potassium sucrose phosphate, sodium sucrose phosphate,sodium phosphate mono basic, sodium phosphate dibasic, sodium phosphatetri-basic, alone or in combination with one or more of the following:calcium fluoride, calcium hydroxide, calcium hydroxy apatite, sodiumfluoride, potassium fluoride, sodium monofluorophosphate.

Surfactants—sodium lauryl sulfate, Polysorbates, Lauryl dimethyl amineoxide, Cetyltrimethylammonium bromide, Polyethoxylated alcohols,Polyoxyethylene sorbitan Octoxynol, N,N-dimethyldodecylamine-N-oxide,Hexadecyltrimethylammonium bromide, Polyoxyl 10 lauryl ether, Polyoxylcastor oil, Nonylphenol ethoxylate, Cyclodextrins, Lecithin,Methylbenzethonium chloride.

Pharmaceuticals—Amoxicillin, amoxil, biaxin, cefzil, cipro, levaquin,minocycline, penicillin, tetracycline, trimox, zithromax, astringentalums.

Nutraceuticals—ascorbic acid, B-glucan, lutein, gallic acid, aloe Vera,lactobacillus acidophilus, zinc, tocopherol, choline, Q-10, B-carotene,lycopene, sodium carbonate, glutathione.

Sweeteners: sucrose, glucose, fructose, phenyl alanine, sucralose,sodium saccharin, xylitol.

Flavors—peppermint oil, methyl salicylate, spearmint oil, cinnamon oil,artificial and natural fruit flavorings like banana flavoring, peachflavoring, and apple flavoring.

Although the present invention has been described with reference topreferred embodiments, numerous modifications and variations can be madeand still the result will come within the scope of the invention. Suchmodifications include increasing or decreasing viscosity and peroxideconcentration for various purposes. No limitation with respect to thespecific embodiments disclosed herein is intended or should be inferred.

What is claimed is:
 1. A dental fluoride delivery device, comprising: abacking material; and a dental composition in contact with the backingmaterial, wherein: the dental composition comprisesPoly(2-ethyl-2-oxazoline) and fluoride; and the dental composition is agelatinous compound having physical deformation properties that allowthe dental composition to bend and conform to a shape of a containerinto which the dental composition is placed, but the dental compositionwill not merge into a second piece of the dental composition when placedin contact with the second piece.
 2. The dental fluoride device in claim1, wherein the backing material is made from a polymeric wax mixture. 3.The dental fluoride device in claim 1, wherein the fluoride is in theform of a fluoride source being selected from the list of fluoridesources consisting of: sodium fluoride, potassium fluoride, stannousfluoride, sodium monofluorophosphate and alkyl fluoroamines.
 4. A dentalfluoride delivery device, comprising: a backing material made from apolymeric wax; a dental composition located on the backing material,comprising: Poly(2-ethyl-2-oxazoline); fluoride; and a solvent; wherein,the dental composition is a gelatinous compound.
 5. The dental fluoridedelivery device in claim 4, wherein the dental composition becomes moreadhesive upon wetting the dental composition with water.
 6. The dentalfluoride delivery device in claim 5, wherein the dental fluoridedelivery device is sized to conform to an individual's dental arch.